This classification decides the validation effort, documentation level, testing depth, and regulatory expectations.
What is a GxP System?
A GxP system is any computerized system that has a direct or indirect impact on:
- Product Quality
- Patient Safety
- Data Integrity
Examples of GxP systems:
- BMS/BAS controlling cleanroom conditions
- LIMS used for QC laboratory results
- EMS monitoring temperature & humidity for stability chambers
- Manufacturing Execution Systems (MES)
- SCADA/HMI controlling critical process parameters
- QMS for Deviations & CAPA
What is a Non-GxP System?
Non-GxP systems do not affect product quality, patient safety, or regulatory decisions. Validation effort here is minimal or not required.
Examples of Non-GxP System:
- HR management systems
- Visitor management systems
- Finance & Payroll systems
- Office productivity tools (email, scheduling)
Read also: Introduction to ISPE GAMP 5 Guide
Reference: GAMP 5 — Category Definitions & Risk-Based Approach.
